510(k) · Cleared
ClearedSpirodoc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical International Research USA, Inc. · BZG Spirometer, Diagnostic
Cleared on Nov 21, 2011 as substantially equivalent to K061712 (Mir Medical Intl. Research Srl, 2006) after a 355-day review. Its family tree reaches back 4 generations to 1994. 4 later devices descend from it.
- Decided
- Nov 21, 2011
- Review
- 355 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K943404 (1994). 9 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK943404 3301 Pulse OximeterBci Intl., Inc. · 1994
- 3 generations backK013171 3420 Digit Pulse Oximeter, Model 3420Bci, Inc. · 2002
- 2 generations backK043528 SpirotelMir Medical Intl. Research Srl · 2005
- 1 generation backK061712 Spirobank IIMir Medical Intl. Research Srl · 2006
- This deviceK103530 SpirodocMedical International Research USA, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK141546 Vitalograph Model 7000 SpirotracVitalograph (Ireland), Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK230501 Spirobank OxiMir Medical International Research USA · 2023
- Descendant · 2 generations on · 0 of its ownK201562 SpirotracVitalograph Ireland, Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK142642 Vitalograph Model 6600 CompactVitalograph (Ireland), Ltd. · 2015
Most influential descendants
Showing 4 of 4 · See all- K141546Vitalograph Model 7000 SpirotracVitalograph (Ireland), Ltd. · 2014 · cites it directly2descendants
- K230501Spirobank OxiMir Medical International Research USA · 2023 · cites it directly0descendants
- K201562SpirotracVitalograph Ireland, Ltd. · 2020 · 2 generations on0descendants
- K142642Vitalograph Model 6600 CompactVitalograph (Ireland), Ltd. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943404 | 3301 Pulse Oximeter | Bci Intl., Inc. | 1994 | — |
| −3 | K013171 | 3420 Digit Pulse Oximeter, Model 3420 | Bci, Inc. | 2002 | — |
| −2 | K043528 | Spirotel | Mir Medical Intl. Research Srl | 2005 | — |
| −1 | K061712 | Spirobank II | Mir Medical Intl. Research Srl | 2006 | — |
| 0 (this device) | K103530 | Spirodoc | Medical International Research USA, Inc. | 2011 | — |
| +1 | K141546 | Vitalograph Model 7000 Spirotrac | Vitalograph (Ireland), Ltd. | 2014 | — |
| +1 | K230501 | Spirobank Oxi | Mir Medical International Research USA | 2023 | — |
| +2 | K201562 | Spirotrac | Vitalograph Ireland, Ltd. | 2020 | — |
| +2 | K142642 | Vitalograph Model 6600 Compact | Vitalograph (Ireland), Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZG device
- #1 K251777 MESI mTABLET SPIROscore 13.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061712 | Spirobank IISummary page 1…dentification of legally marketed device to which the submitter claims equivalence: Company Name: MIR Device Name: Spirobank 11 5 10(k) number: K061712 4. Description of the device: Spirodoc is a pocket-size spirometer and oximeter. The device is made up of: - a central uni… | 2006 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K141546 (Vitalograph (Ireland), Ltd., 2014) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K061712.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · BZG
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZG
362in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZG
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZG
1in 2025
MAUDE reports naming product code BZG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 121 | 0 | 1 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 8 | 141 | 0 | 0 |
| 2010 | 4 | 181 | 0 | 0 |
| 2011 | 6 | 278 | 0 | 1 |
| 2012 | 3 | 59 | 0 | 2 |
| 2013 | 3 | 266 | 0 | 1 |
| 2014 | 5 | 154 | 0 | 1 |
| 2015 | 5 | 273 | 0 | 1 |
| 2016 | 4 | 235 | 0 | 1 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 3 | 146 | 0 | 1 |
| 2020 | 5 | 126 | 0 | 2 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 3 |
| 2023 | 5 | 362 | 0 | 2 |
| 2024 | 2 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Spirodoc Spirometer and pulse oximeter is intended to be used by
a physician or by a patient under the prescribed use of a physician.
The device is intended to test lung function and can perform spirometry testing in adult and
pediatric patients, excluding infants and neonates, and oximetry readings in patients of all
ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103530 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103530: Spirodoc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103530
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026